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Establishing a QMS

A Year of Scale, Support, and Celebration

December 20, 2022
Greenlight Guru ranks as the #1 QMS and Medical QMS in 2022 Read More
Product Development

Randomization in Medical Device Clinical Trials: Everything You Need to Know

December 20, 2022
The purpose of MedTech clinical investigations is to gain insights about the safety and effectiveness of a medical device. To ensure the quality of those insights, clinical... Read More
Product Development

Design Controls Need to Start With User Needs

December 19, 2022
In the FDA’s classic design control waterfall diagram, the box at the left-hand top of the waterfall is labeled “user needs.” Read More
Product Development

The Importance of Management Reviews for CAPAs

December 18, 2022
The corrective and preventive action process is a cornerstone to a healthy QMS, and provides oversights, insights, and checks and balances for nonconforming products and... Read More
Product Development

CAPA Best Practices: 4 Tips for Building an Excellent CAPA Process

December 16, 2022
An effective CAPA process is one of the most important parts of your quality management system (QMS). It’s your tool for addressing systemic or highly critical issues in your... Read More
Product Development

How Technology Can Support Clinical Trial Continuity & Data Integrity

December 15, 2022
The Covid Pandemic impacted the way we live and work. Its impact was felt on every aspect of what we did and no industry was immune. Naturally, that means that the MedTech... Read More
Product Development

Ultimate Guide to Device Class Requirements under EU MDR

December 11, 2022
Marketing a device in the European market means complying with the numerous safety and technical requirements of the Medical Device Regulation (MDR). In practice, this can be... Read More
Product Development

Electronic Data Capture for Medical Devices: Then vs. Now

December 9, 2022
Decades ago, data from clinical trials could only be captured using paper Case Report Forms (CRFs). Researchers would fill out the CRFs by hand at the site of the clinical... Read More
Product Development

How to Use SMART-TRIAL by Greenlight Guru's ePRO Module

December 9, 2022
SMART-TRIAL by Greenlight Guru is the only MedTech specific electronic data capture (EDC) system. One of the first features built into our EDC system was an integrated e-mail... Read More

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